Medical Device Reporting SOP

Compass Health SOP: Medical Device Reporting and Mandatory Problem Reporting

• Purpose: To provide a system and instructions for assigning responsibilities and duties for the compliance of Compass Health with Medical Device Reporting regulations (21 CFR Parts 803 and 820.198, and CMDR).

• Scope: Applicable to all Compass Health medical devices released for distribution in the US, incidents occurring outside the US for US-distributed products, all devices released for distribution in Canada and Australia.

Applicable Standards, Guidance and Forms

• FDA - 21 CFR Part 803: Medical Device Reporting regulations.
• FDA MedWatch forms: Used for FDA safety reporting (Form 3500, 3500A, and 3500B) and further guidance documents.
• FDA - 21 CFR Part 806: Removals and Corrections.
• Health Canada - CMDR: Mandatory Problem Reporting guidelines
• Various other guidance documents (from FDA and Health Canada): Refer to specific URLs for details.

Reference Documents

• SOP: Complaint Handling: (QMS-SOP-0026)

Acronyms and Definitions

• Complaint: A complaint communicated in written, oral, or electronic format alleging deficiencies in a medical device.
• Malfunction: A failure of a medical device to perform as intended.
• Medical Device Report (MDR): A mandatory report for a complaint, that requires reporting to FDA (21 CFR Part 803).

Reportable Events (US)

• Event: An event that suggests a device may have caused or contributed to death or serious injury.
• Manufacturer/Importer: An event that suggests a device marketed could cause death or serious injury if the malfunction recurs.

Reportable Events (Canada)

• Device Sold in Canada: An incident related to device failure, deterioration, labelling or directions for use leading to a patient's serious deterioration in health, or potential for such deterioration if the incident recurs.
• Device Sold Outside of Canada: A similar event, but only if the manufacturer or importer has indicated corrective action to a regulatory agency of the country in which the incident occurred, or if the regulatory agency required corrective action.

Becoming Aware

• Timeline: 30 calendar days (or, in certain cases 5 working days).

Aware Date

• Definition: The date the Compass Health personnel first becomes aware of the complaint information.

Individual Adverse Event Data (US & Canada)

• 5-day report (US): For MDR reportable events requiring remedial action to prevent harm to public health.
• 30-day report (US): For events that suggest a device resulted in death/serious injury.
• Incident Reporting in Canada: Event and information submission within 10 calendar days of aware date if death or injury occur on Canadian soil, or within 30 days if not or within 48 hours of foreign regulatory agency action.

Mandatory Problem Reporting (MPR)

• Definitions Event involving a medical device sold in Canada , that relates to a device malfunction, poor labeling, etc. and results in a patient's serious deterioration of health which may or may not recur.

Abnormal Use

• Definition: A user's actions that exceed reasonably anticipated risks, often resulting in a use beyond intended purpose.

Complainant

• Definition: The person who first reported the incident.

Correction

• Definition: Action to eliminate a nonconformity (e.g., repair, modification).

Corrective Action

• Definition: Specific action to eliminate current problems with a device (rather than preventing future issues).

Importer

• Definition: A person who brings the medical device into Canada for sale, other than the manufacturer.

Incident

• Definition: The circumstances of the problem relating to a medical device report.

Individual Adverse Event

• Definition: An event resulting in substantial deterioration relating to the use or intended use of the medical device.

Manufacturer

• Definition: The person accountable for designing, manufacturing, assembling, packaging a medical device or for assigning it a purpose.

Malfunction (Deterioration)

• Definition: A device's failure to perform as intended, when used correctly.

Preventive Action

• Definition: An action to prevent the occurrence of a problem.

Recall

• Definition: Action to remove or correct a faulty device from the market.

Process Roles

• Responsibilities and tasks of individuals (e.g., QA/RA, Compass Health, Compass Health U.S. Agent) and reporting procedures are outlined.

Process Monitoring

• QA/RA: Responsible for ongoing support of the mandatory problem reporting process and ensuring timely filings of MDR/MPR reports.

Quality Records

• MDR/MPR Records: Includes all the preliminary and final reports submitted to relevant regulatory agencies and are stored separately from other complaints.

Medical Device Report Decision Trees

• FDA Decision Tree: An outline and visual guidelines for reporting decisions specific to medical device events and problems, when it's required to report to the FDA.
• Health Canada Decision Tree: Visual guidelines for reporting medical device events/problems to Health Canada.
• Australia TGA Decision Tree: Visual guidelines for reporting medical device events/problems to the Australian TGA.

Foreign Incidents

• Definitions: Medical device incidents occurring outside a jurisdiction.
• Reporting Requirements: Specific to the reporting timeline and procedure for these events.

Summary Reports

• Summary Report Requirements: For medical devices with specific licenses, and the criteria under which summary reports need to be prepared.

Notifying Health Canada

• Notifications: Guidance on how Compass Health will notify Health Canada about changes in benefits/risks of a medical device.

Submitting an eMDR

• Process: Compass Health's official correspondent submits all Medical Device Reports to the FDA in an eMDR format.